US Patient Safety Specialist/Scientist Patient Safety

Job Details
Job Location: **ONSITE in Wilmington, DE**
Internal Job Title : US Patient Safety Specialist
Must Haves: *Five years of experience in a hospital, pharmaceutical, clinical research position, or other healthcare related field, to include at least 2 years of Patient Safety experience*
Description
The US Patient Safety Specialist serves as a Medical and Safety resource for synthesis, analysis, evaluation, and reporting of adverse event information in order to maintain an accurate safety profile of Client products. The US Patient Safety Specialist serves as vital link in the timely classification, analysis and summarization of both investigational and post-marketed adverse event information and support to the product teams. The US Patient Safety Specialist supports the multidisciplinary teams and other cross-functional teams within Client to provide case handling and safety support to licensing agreements, clinical study agreements and special projects.
Accountabilities/Responsibilities
Five years of experience in a hospital, pharmaceutical, clinical research position, or other healthcare related field, to include at least 2 years of Patient Safety experience
Participates in the triage process for incoming documents to insure timely and effective medical and scientific evaluation of adverse event information
Request follow-up information from consumers, and health care professionals and requests clarification from foreign affiliates according to specific report types using both global and local SOP timeframes
Reviews adverse event documents prepared by the Patient Safety personnel for accuracy, completeness, and validity prior to submission to the FDA
Have a broad understanding of Support & Surveillance activities and the impact on individual case or group of cases can have on product labelling
Leads team in preparing, organizing, and reviewing tabulations for Regulatory reports
Represents US Patient Safety in Licensing Agreement review and process teams
Represents US Patient Safety for Clinical Trial protocol and safety handling plan review and process teams
Assumes responsibility for completing special projects (i.e. CIPs, representation on cross functional teams)
Supports Safety Surveillance, Safety Support - Compliance and Marketing Company and US Medical Affairs and the US Clinical Teams
Serves as a knowledge resource for departmental personnel regarding medical, scientific and Operational issues
Demonstrates ability to communicate effectively with personnel of various disciplines regarding aspects of product inquiries, collection of safety data and FDA processes and regulations
Reflects the Patient Safety philosophy of being a team player and supports the development of those individuals within the department
Working knowledge of technology required for Patient Safety
Excellent knowledge of FDA and ICH guidelines and reporting requirements
Initiates and volunteers for special projects
Demonstrated ability to perform with minimal supervision
Demonstrates leadership capabilities at target level or above
Ability to travel domestically for yearly business meeting